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Details for New Drug Application (NDA): 078069

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NDA 078069 describes OXCARBAZEPINE, which is a drug marketed by Taro, Glenmark Generics, Ani Pharms Inc, Sun Pharm Inds Ltd, Cadista Pharms, Apotex Inc, Amneal Pharms, Breckenridge Pharm, Roxane, and Sun Pharm Inds, and is included in eleven NDAs. It is available from twenty-four suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are eighteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for NDA: 078069

Breckenridge Pharm
Therapeutic Class:Anticonvulsants

Pharmacology for NDA: 078069

Suppliers and Packaging for NDA: 078069

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078069 ANDA REMEDYREPACK INC. 49349-083 49349-083-02 30 TABLET in 1 BLISTER PACK (49349-083-02)
TABLET;ORAL 078069 ANDA REMEDYREPACK INC. 49349-261 49349-261-02 30 TABLET in 1 BLISTER PACK (49349-261-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 11, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jan 11, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jan 11, 2008TE:ABRLD:No

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